UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029047 |
|---|---|
| Receipt number | R000033226 |
| Scientific Title | Research on measurements of brain metabolites including glucose using 7T-MRI |
| Date of disclosure of the study information | 2017/09/07 |
| Last modified on | 2019/09/09 09:32:26 |
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Basic information
Public title
Research on measurements of brain metabolites including glucose using 7T-MRI
Acronym
Research on measurements of brain metabolites using 7T-MRI
Scientific Title
Research on measurements of brain metabolites including glucose using 7T-MRI
Scientific Title:Acronym
Research on measurements of brain metabolites using 7T-MRI
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Research on measurement methods for brain metabolites using 7T-MRI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Agreementof blood glucose level and MR-measured glucose level.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Data acquisition using a non-certified 7T-MRI system for clinical use.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who will participate in this study on his or her volunteer will and gave written informed consent.
Key exclusion criteria
DM patients under treatment and those who are contraindicated to MR examination checked with the pre-MRI check sheet.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomohisa |
| Middle name | |
| Last name | Okada |
Organization
Kyoto University
Division name
Human Brain Research Center, Graduate School of Medicine
Zip code
606-8507
Address
54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
0757513602
tomokada@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Okada |
Organization
Kyoto University
Division name
Human Brain Research Center, Graduate School of Medicine
Zip code
606-8507
Address
54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
0757513695
Homepage URL
tomokada@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Human Brain Research Center, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Siemens Healthcare, K.K.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital Ethics Committee
Address
Yoshida Konoecho, Sakyoku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 11 | Month | 18 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 07 | Day |
Last modified on
| 2019 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033226
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
